一项全球研究,评估 rilvegostomig 对比安慰剂联合研究者选择的化疗,用于接受根治性意图手术切除后胆道癌(BTC)参与者的疗效及耐受性。
适应症:Biliary Tract Cancer
入组条件
纳入标准
- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
- Provision of a tumor sample collected at surgical resection.
- Randomization within 12 weeks after resection with adequate healing and removal of drains.
- Confirmed to be disease-free by imaging within 28 days prior to randomization.
- Eastern Cooperative Oncology Group performance status of 0 or 1
排除标准
- Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
- Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
- Any anti-cancer therapy for BTC prior to surgery
- Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
- Current or prior use of immunosuppressive medication within 14 days before the first dose
- Thromboembolic event within 3 months
- Active HBV or HCV infection unless treated.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。